EMERGE Mothers and Kids

National University of Ireland, Galway, Ireland

Status: Enrolling

Conditions: Gestational Diabetes

Treatments: Other: No intervention as the study is observational.

Study type: Observational

Funder types: Other

Identifiers

NCT06327191

23-CRFG-21 (Other Identifier)

Details and patient eligibility

About

The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality.

The primary objectives of the EMERGE Mothers and Kids follow up study are:

1. to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 10 years post the index pregnancy;
2. to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration;
3. to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up;
4. to determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds.

Enrollment: 321 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in the original EMERGE trial and consenting to further follow up.

Exclusion criteria

• EMERGE trial participants who did not provide consent for further follow up studies.